AUDICOR CPAM WITH SDB (SINGLE SENSOR)

AUDICOR CPAM WITH SDB (SINGLE SENSOR) is an FDA 510(k)-cleared medical device (K130660) manufactured by Inovise Medical, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 10, 2013. Regulation: 8.